MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS GS PREMIUM; ANESTHESIA UNITS

Model Number	8607000
Medical Device Problem Codes	Degraded (1153); Failure to Deliver (2338); No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still on going.The results will be provided with a follow-up report.
Event or Problem Description
It was reported that the ventilator stopped while in a case.There was no patient injury reported.
Additional Manufacturer Narrative
The device is maintained by an in-house biomed who was seeking dräger's assistance.Upon review of the provided log file dräger recommended to replace the ventilator motor which reportedly has resolved the problem.The log file entries indicated that the supervisor software detected a deviation between the measured and the expected motor position.The safety concept can be explained as follows: the ventilator motor is a step motor that drives a piston i.E.The number of rotations and the end position defines the piston hub; the piston hub is an equivalent to the tidal volume applied to the patient.To protect the patient from potentially hazardous output and/or from serious damages to the ventilator unit, the device is designed to shut down automatic ventilation when the divergence between expected and measured motor position exceeds a certain limit.The user will be alerted to the shutdown by means of a corresponding alarm, and manual ventilation with the built-in breathing bag including gas dosage will further be possible.Since the nature of the issue is known and the related failure rate is within accepted range, an evaluation of the failed motor was not considered necessary.
Event or Problem Description
It was reported that the ventilator stopped while in a case.There was no patient injury reported.

• Brand Name: FABIUS GS PREMIUM
• Common Device Name: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 22736369
• Report Number: 9611500-2025-00439
• Device Sequence Number: 13087841
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)200128(93)8607000-75
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8607000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown